Orthalign, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000027362 FEI 3007521480
- Devices
- 398
- Registrations
- EUDAMEDFDA
- FDA recalls
- 22 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- MDSS GmbHDE
What Orthalign, Inc. makes
Orthalign, Inc. makes orthopaedic surgical procedure kits that are non-medicated and reusable, orthopaedic stereotactic surgery systems, non-bioabsorbable sterile bone screws, and robotic surgical arm systems. Specific devices in their portfolio include KneeAlign 2, OrthAlign Plus, and the Lantern Surgical Assistant (LSA).
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA UDI registry. Orthalign, Inc. is based in the United States.
Catalogue
Search and filter all 398 devicesShowing 1-50 of 398
Company details
- EUDAMED SRN
- US-MF-000027362
- FDA FEI number
- 3007521480
- DUNS number
- 023266163
- EUDAMED status
- Active
- EUDAMED registered name
- OrthAlign, Inc
- Registered address
- 153, Technology, 92618, Irvine, United States
- Website
- www.orthalign.com
- [email protected]
- Phone
- 949.715.2424
- PRRC contact
- Karyl Haskell
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 2
2026
- 10 Feb 2026 Z-1629-2026 Class II Ongoing Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
- 10 Feb 2026 Z-1630-2026 Class II Ongoing Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Frequently asked questions
How many devices does Orthalign, Inc. have in the registry?
The registry currently lists 398 devices for Orthalign, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthalign, Inc.'s devices?
Among its 50 most recently registered devices, Orthalign, Inc. has devices listed in EUDAMED (2 devices), FDA 510(k) (2 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Orthalign, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Orthalign, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Orthalign, Inc.?
FDA recall records list 2 recalls initiated by Orthalign, Inc., the most recent initiated on 10 Feb 2026. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Orthalign, Inc. in the registry?
The most recently registered devices listed for Orthalign, Inc. include Lantern ASC 503000, Lantern ASC 407001-02, Lantern 405310 and Lantern ASC 407001-01.